A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease

Hoffmann-La Roche82 enrolled

Overview

This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Interventions

PlaceboDRUG

Oral daily doses for 12 weeks

RO5093151DRUG

Oral daily doses for 12 weeks

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, 35-65 years of age * Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat \>5.56% at screening * Body mass index (BMI) \>27 kg/m2 at screening * Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) \> 2.5 at screening * Agreement to maintain prior diet and exercise habits during the full course of study Exclusion Criteria: * History of diabetes mellitus based on World Health Organization (WHO) criteria * Known polycystic ovary syndrome * Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis * Known autoimmune disease or chronic inflammatory disease * Myocardial infarction or stroke within 6 months prior to screening * Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening

Locations (4)

Unnamed facility

Vienna, Austria

Unnamed facility

Düsseldorf, Germany

Unnamed facility

Nuthetal, Germany

Unnamed facility

Tübingen, Germany

Outcomes

Primary Outcomes

Change of liver fat content measured by magnetic resonance spectroscopy (MRS)

Time frame: Week 12

Secondary Outcomes

Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp

Time frame: Week 12

Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp

Time frame: Week 12

Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)

Time frame: Week 12

Safety (incidence and nature of adverse events)

Time frame: Week 12

Data from ClinicalTrials.gov

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